Syngo®.via ProtoNeo (Version VA10A)
System, Image Processing, Radiological
SIEMENS HEALTHCARE GMBH
The following data is part of a premarket notification filed by Siemens Healthcare Gmbh with the FDA for Syngo®.via Protoneo (version Va10a).
Pre-market Notification Details
| Device ID | K161685 |
| 510k Number | K161685 |
| Device Name: | Syngo®.via ProtoNeo (Version VA10A) |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS HEALTHCARE GMBH HENKESTRASSE 127 Erlangen, DE 91052 |
| Contact | Lauren Bentley |
| Correspondent | Georg Bauer TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-06-17 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869012971 | K161685 | 000 |
Trademark Results [Syngo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNGO 76166029 2623451 Live/Registered |
SIEMENS HEALTHCARE GMBH 2000-11-15 |
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